In patients with psoriatic arthritis (PsA), early treatment initiation with golimumab plus methotrexate (MTX) was associated with a nearly 2-fold improvement in remission compared with the use of MTX alone, according to study results published in Annals of the Rheumatic Diseases.

The multicenter, investigator-initiated, double-blind, randomized, placebo-controlled study (ClinicalTrials.gov identifier: NCT01871649) was conducted at 3 centers in The Netherlands between September 2013 and September 2017. The investigators sought to explore whether combination therapy with golimumab plus MTX as a first-line treatment in patients with PsA was superior to MTX alone at inducing disease remission. A total of 51 MTX- and biologic disease-modifying antirheumatic drug (bDMARD)-naïve patients with PsA, according to Classification Criteria for Psoriatic Arthritis (CASPAR), who had active disease at baseline (≥3 swollen joint count/tender joint count) were enrolled in the study. All participants were age 18 to 70 years.

All participants were randomly assigned to receive 5 injections of golimumab 50 mg or placebo administered subcutaneously each month. In both treatment groups, oral MTX was initiated at a dose of 15 mg per week and increased to 25 mg per week over 8 weeks. The primary study end point was the percentage of patients who attained Disease Activity Score (DAS) remission (<1.6) at 22 weeks. Safety was evaluated throughout the duration of the study. Overall, 26 patients were randomly assigned to golimumab 50 mg monthly plus MTX (tumor necrosis factor inhibitor [TNFi] group) and 25 patients were randomly assigned to matched placebo plus MTX (MTX group).

Results of the study demonstrated that the primary efficacy end point was achieved by 81% of patients in the TNFi group and 42% of patients in the MTX group (P =.004). The difference in DAS remission was observed as early as 8 weeks following study initiation. A significant difference in favor of the TNFi group was also reported with respect to such other response criteria as Minimal Disease Activity (P <.001) and 20%, 50%, and 70% improvements in American College of Rheumatology criteria (P =.039, P =.001, and P =.001, respectively).

Regarding safety findings, the rates of adverse events and treatment-emergent adverse events were similar in both treatment groups.

The investigators concluded that early intervention with TNFi therapy in patients with PsA, rather than the use of the classical step-up approach, is linked to the attainment of disease remission. Additional studies are warranted to confirm whether the responses reported in this study can be maintained up to 50 weeks on MTX monotherapy.